Stratafix Vs. Vicryl OAGB / MGB Suture Study

Not Applicable

Completed

• Conditions: Morbid Obesity; Anastomotic Leak; Anastomotic Stenosis; Hemorrhage Postoperative
• Interventions: Device: Stratafix; Device: Vicryl

• Registration Number: NCT04613635
• Lead Sponsor: St. Franziskus Hospital

Brief Summary

To compare shorttime (6 months) results of two competitive suture materials with regard to time demanded to perform the concerned surgical step and secondary to study anastomotic site safety and complications like leakage and hemorrhage as well as development of anastomotic strictures. Evaluation of cost-effectiveness.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-03
• Study Start: 2020-11-06
• Primary Completion: 2023-10-27
• Study Completion: 2024-04-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• adult patients selected for primary Mini-Gastric bypass to treat obesity (BMI>30)
• laparoscopic access feasable (intention to treat laparoscopically)
• failed conservative treatment (accepted by health insurance companies)
• relevant co-morbidities in cases with BMI <40
• age 18 years or elder

Exclusion Criteria

• severe language problems
• revisional or redo-procedures
• operation intended as open procedure(extensive previous surgeries),
• operation performed under corticoid-medication
• operation performed under full-dose anticoagulants
• operation performed by another surgeon than one of the 3 experienced MGB-surgeons of the Department

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stratafix	Stratafix	-
Vicryl	Vicryl	-

Primary Outcome Measures

Name	Time	Method
Closure of gastrojejunostomy	The assessment of this surgical step will be completed during the operation.	time needed to perform this specific surgical step, i.e. the ventral defect closure of the (otherwise stapled) gastrojejunostomy

Secondary Outcome Measures

Name	Time	Method
anastomotic site perioperative morbidity	6 months	Number of participants with hemorrhage, leakage or symptomatic strictures requiring further diagnostic or therapeutic measurements
other anastomosis- related morbidity	6 months	Number of participants with marginal ulcer or anastomotic stricture needing further diagnostic and/or interventions
economical factors	6 months	costs of treatment in case the above mentioned complications occur and require intervention

Trial Locations

Locations (1)

St. Franziskus-Hospital; 🇩🇪 Cologne, Germany